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Zofran, an anti-nausea medication intended for use only by surgery and chemotherapy patients, has been prescribed heavily in the past numerous to pregnant women experiencing morning sickness. Consequently, some of the women who took Zofran while pregnant gave birth to babies to with birth defects. One of the most severe birth defects associated with Zofran is heart malformations, including “Tetralogy of Fallot” heart defects.

What is Tetralogy of Fallot?

According to the National Heart, Lung, and Blood Institute, Tetralogy of Fallot is a congenital heart birth defect that is present shortly after an infant is born. It’s a rare disease, occuring in around 5 of every 100,000 live births.
doctor listens to the heart with stethoscope
Tetralogy of Fallot causes four different heart defects and is considered a severe, life-threatening condition. The following conditions are present when an infant develops Tetralogy of Fallot:

Right Ventricular Hypertrophy

Right Ventricular Hypertrophy is a birth defect that makes the infant’s right ventricle muscle too thick. It happens when the heart has to work more than normal when moving blood through the pulmonary valve.

Overriding Aorta

An overriding aorta is a defect in the aorta that’s marked by an extremely poor flow of oxygen blood from the flow of the right ventricle into the aorta.

Ventricular Septal Defect

Ventricular Septal Defect (VSD)  is a hole in the septum, the partition that separates the heart’s two chambers. When there is a hole in the septum, it allows the oxygen-rich blood from the left ventricle to combine with the right ventricle’s oxygen-poor blood.

Pulmonary Stenosis

Pulmonary Stenosis is a heart defect marked by a narrowed pulmonary valve, as well as the passage from the right ventricle to the pulmonary artery. Pulmonary Stenosis causes the pulmonary valve to fail to open the way it normally should. In turn, the heart has to work double-time in order to pump the required blood through the pulmonary valve. Consequently, the infant’s lung do not get enough blood.

Tetralogy of Fallot Symptoms

Symptoms of the disorder will vary, but the most common symptoms of Tetralogy of Fallot include:

  • Rapid breathing and shortness of breath
  • A bluish tint to the skin
  • Low weight gain
  • Clubbed foot and hand
  • Heart murmurs
  • Excessive crying
  • Tiring easily
  • Fainting

What is Tetralogy of Fallot Treatment Options

In order to treat Tetralogy of Fallot, open heart surgery is usually required. Babies generally have the surgery either shortly after birth or within the first year of life, depending on how severe the condition is. For example, infants with an extremely narrow pulmonary artery will usually have surgery right away.

Tetralogy of Fallot Causes

There are numerous reasons that Tetralogy of Fallot may occur, including poor maternal nutrition, older maternal age (age 40 and over), drinking alcohol while pregnant, and maternal viruses. However, recent research indicates that taking Zofran while pregnant may increase the risk of infants developing Tetralogy of Fallot.

In fact, in July 2105, an Illinois couple filed a lawsuit against GlaxoSmithKline, the makers of Zofran, after their infant son was born with Tetralogy of Fallot. The mother, who was healthy during pregnancy and didn’t have any factors that would cause the defect, was prescribed Zofran in her first trimester of pregnancy after experiencing severe morning sickness.

Consequently, after her baby was born with Tetralogy of Fallot, he had go undergo open heart surgery in addition to numerous other treatment procedures.

Zofran and Birth Defects

Keep in mind that Zofran was never intended for and is still not approved for use by pregnant women. To get around the legal loophole, doctors have been prescribing the medication as “off label” use for morning sickness. In addition, GSK marketed the drug for morning sickness while ignoring studies that indicate the the drug may increase the chances of infants developing life-threatening birth defects.

If you took Zofran and it’s injured your baby, you have the legal right to file for compensation against the responsible party. For additional information, refer to our article, Zofran Lawsuit.